`
`UNITED STATES PA'I‘EN'I‘ AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMIHERCE
`United States Patent and Trademark ()lfice
`Address; COMMISSIONER FOR PA'I'IEN'I'S
`PD. Boa [450
`Alexandria, V i Igi I1i:| 2 2.1.13 - I 450
`w ww . "splay-«1v
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`21‘???
`
`T59”
`
`UfiftflflIII-i
`
`BERNARD l". PLANTZ.
`JOIINSON 8; JOHNSON
`ONF, JOIINSON 8; JOHNSON PLAZA
`
`NEW BRUNSWICK. NJ 03933—J003
`
`EXAMINER
`
`III.II.SAN MING R
`
`162]
`
`DATE MAILED: WOEIEDH
`
` APPLICATION NO.
`
`Alan H. Auerbach
`DEEMED] 1
`l3f034,340
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`CGRSOOIIJ'SCNTI
`
`|59T
`
`FILING DATE
`
`FIRST NAMED INVIENTOR
`
`ATTORNEY DOCKET NO.
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`('ONI'TRAI'LA'I'ION NO.
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` APPLN TYPE
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`ENTITY STATUS
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`ISSUE FEE DUE
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`TOTAL FEELS] DUE
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`PTOI.—85 (Rev. 02;” l)
`
`Fag“ ' 0”
`
`JANSSEN EXHIBIT 2166
`Wockhardt v. Janssen |PR2016-01582
`
`JANSSEN EXHIBIT 2166
`Wockhardt v. Janssen IPR2016-01582
`
`

`

`PART B - FEELS) TRANSMITTAL
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`7590
`27???
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`transmitted to the USPTO (. 71) 273—2385. on the date indicated below.
`
`NEWBRUNSWICKWQBJOm
`
` APPLICA'I'ION N0.
`
`Alan H. Auerhach
`0324201 1
`13f0114,340
`TITLE 01" INVENTION: ME'I'I IODS AND COMPOSITION S FOR TREATING CANCER
`
`CGRSOO I USCNTI
`
`159?
`
`FILING DATE
`
`FIRST NAJN'IIEI) INVI'IN'I‘OR
`
`A'I'IURNILY DIIXIKIE'I' NO.
`
`t.'()N'I-'IRMA'1'1()N N0.
`
`APPIN. TYPE
`I'IN'I'I'I'Y S'I'A'I'liS
`ISSUE I'lili DUE
`111.7131 .I(.'A'I‘ION 1"1‘21'2 DUE
`PR1 EV. PAID ISSUE l"IiE
`'I‘O'I'AI. 1-1-21 its) DUI-I
`DA'I'I'I DUE
`
`nonprovisional
`UND ISCOI iNTED
`$960
`$0
`$960
`oeromm 4
`
`
`EXAMINER
`ART l..‘-N1T
`CLASS-S UB CLASS
`
` |
`
`111.71. SAN MING R
`
`1621
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`514—170000
`
`. Change of correspondence address or indication of "Fee Address" (37"
`CFR 1.363].
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`Address orm P11312811}.Ir 122} attached.
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`Page 2 of 3
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`P't'OL—SS Part B { |tJ~ 13] Approved for use through 1013112013.
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`OMB 0651—0033
`
`Us. Patent and 't'rademark Office: U .S. DEPAR'I'MEN'I' 01" COMMERCE
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`

`

`
`
`UNITED S'i‘A’iES PA'rEN'r AND TRADEMARK OEHCE
`
`UNITED STATES DEPARTMENT OF CDAIMERCE
`United States Patent and Trademark Olfiue
`Address: COMMISSIONER FOR I’A'I'IEN'I'S
`PD. Bat 1-1-50
`Alexamlrizl, Virginia 231134-150
`www.|lsplo.guv
`
`APPLICATION NO.
`FILING DATE
`FERST NAMED INVENTOR
`ATTORNEY DOCKET NO.
`CONFIRMATION NO.
`
`13I034.340
`03241201]
`Alan II. Aucrbach
`CGRSOU] USCN'J']
`159?
`
`BERNARD 1". PLANTZ
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`
`NEW BRUNSWICK. NJ 08933-7003
`
`IIUI. SAN MING R
`
`162]
`
`DATE MAILED: WOEIEOH
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 0))
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`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`Section l(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i)
`requirement
`that
`the Office provide a patent term adjustment deteimination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. I9416, 194]? (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent temi adjustment determination with the notice of allowance. The Office will continue to
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`PTO].—85 (Rev. DUI I)
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`Page 3 of 3
`
`

`

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`
`

`

`
`
`.
`.
`.
`Notice of Aflowabrirty
`
`Applicantis)
`Application No.
`
` 13r034,34o AUERBACH ET AL.
`-
`'
`AIA (First Inventor to
`31$er HUI
`3‘32?“
`Fm.) Status
`No
`
`-- The MAtLiNG DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable. PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. E This communication is responsive to 5/9/2014.
`
`El A declaration (s)laffidavit(s) under 37 CFR 1.130(b) wasiwere filed on
`
`2. I] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`; the restriction
`
`3. E The allowed claim(s) isr‘are 37—56. As a result of the allowed claim(s), you may be eligible to benefit from the Patent Prosecution
`Highway program at a participating intellectual property office for the corresponding application. For more information, please see
`:fx‘wwwus to.
`atentsr'init events!“
`hr'insziex.'s' or send an inquiry to PPHE‘eedbackr us' tooov .
`
`4. I] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d} or (f).
`
`Certified copies:
`
`a) [I All
`
`b) I] Some
`
`*c) I] None of the:
`
`1. El Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No.
`
`3. El Copies of the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`
`" Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE” of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. I] CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`
`El
`
`including changes required by the attached Examiner‘s Amendment i Comment or in the Office action of
`Paper NojMaiI Date
`Identifying indicia such as the application number (see 3? CFR 1 .84th) should be written on the drawings in the tront (not the back) of
`each sheet. Replacement sheet(s} should be labeled as such in the header according to 37 CFR 1.121 (d).
`
`6. El DEPOSIT OF andior INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`
`
`Attachmentts)
`1. I] Notice of References Cited (PTO-892)
`
`2. [:I Information Disclosure Statements (PTOISBIOB),
`Paper No.iMai| Date
`3. El Examiners Comment Regarding Requirement for Deposit
`of Biological Material
`4. I] Interview Summary (PTO-413),
`Paper NoJMaiI Date
`
`5. El Examiner‘s AmendmentiComment
`
`6. E Examiner's Statement of Reasons for Allowance
`
`7. El Other
`
`JSAN-MING HUI!
`
`Primary Examiner, Art Unit 1621
`
`
`US. Patenl and Trademark Office
`
`PTOL—S? (Rev. 08—13)
`
`Notice 01 Allowability
`
`Part of Paper NoJMail Date 20140519
`
`

`

`Application/Control Number: 13034340
`
`Page 2
`
`Art Unit: 1621
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Continued Examination Under 37 OFF? 1.1 14
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office
`
`action under Ex Parie Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since
`
`this application is eligible for continued examination under 37 CFR 1.114, and the fee
`
`set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has
`
`been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 5/9/2014 has
`
`been entered.
`
`REASONS FOR ALLOWANCE
`
`The following is an examiner’s statement of reasons for allowance: the herein
`
`claimed method of treating prostate cancer is essentially the same as the notice of
`
`allowance mailed 2i11i2014. The commercial success of the combination of prednisone
`
`and abiraterone to treat prostate cancer obviate the rejection under 35 USC 103(a).
`
`Claims 37-56 are allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SAN-MING HUI whose telephone number is (571 )272-
`
`0626. The examiner can normally be reached on Mon - Fri from 9:00 to 5:00.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner‘s
`
`supervisor, Melenie McCormick can be reached on (571) 272-8037. The fax phone
`
`

`

`Application/Control Number: 13034340
`
`Page 3
`
`Art Unit: 1621
`
`number for the organization where this application or proceeding is assigned is 571 -
`
`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`San-ming Hui
`Primary Examiner
`Art Unit 1621
`
`ISAN-MING HUI/
`
`Primary Examiner, Art Unit 1621
`
`

`

`
`
`ApplicationIControl No.
`
`Search Notes
`
`13034340
`
`Applicant(s)r’Patent Under
`Reexamination
`
`AUERBACH ET AL.
`
`
`
`
`
`
`SAN-MING HUI
`
`Examiner
`
`CPC- SEARCHED
`
`Examiner
`
`CPC COMBINATION SETS - SEARCHED
`
`Examiner
`
`Date
`
`SHExaminer
`
`
`
`US CLASSIFICATION SEARCHED
`
`
`
`170 182
`1127711
`170,182
`91'51’12
`
`170 182
`2125113
`514
`SH
`514
`170,182
`6128113
`SH
`170 182
`10121113
`
`170,182
`1f29f14
`514
`SH
`514
`170,182
`51’191’14
`SH
`
`Subclass
`
`SEARCH NOTES
`
`
`
`Search Notes
`Date
`Examiner
`
`EAST search and inventor search in PALM
`1127i“
`SH
`EAST search and inventor search in PALM
`95112
`SH
`EAST search and inventor search in PALM
`225113
`SH
`EAST search and inventor search in PALM
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`Application Number
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`130343d0
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`Filing Gate
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`20‘: 1—02—24
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`lNFGRMATiQN BESCLGSERE
`
`
`First Named inventor
`Aien H. Auerbach
`
`STfiiEMENT BY APPLlCANT
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`(_ Not for submission under 3? CFR 1.99)
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`Alt Unit
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`Examiner Name
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`Sen Ming R. Hui
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`(book, magazine, journal, serial, symposium, catalog, etc), date. pagesie}, volume—issue numberis},
`pubiisher. city andior one ntry' where published.
`
`Assessment Report for Zytiga (abiraierone) published 2011 by the CHMP oi the EMA
`
`AUCHUS, R..l., “The genetics, pathophyeioicgy, and the management oi human deficiencies of P45tie17", Endocrine-l
`Metab C—lin Netti: Am (2091), 3'23, owl-“:19
`
`AYUES, l‘vi" “inhibition ofteetioular i'Fa—iiycitoxyiese ano‘ ’i‘i’EO—iyase but not 38—hydroxysteroid dehydrogeneee-
`isomerase or 1?B--hydroxyeieroid oxidorediioiese by kelzooonazole and other imidazoie drugs, Journal of Steroid
`Biochemistry {1987;- 28(5), 9521-53“:
`
`T5i
`
`‘
`
`:
`
`Campbell-Welsh Ute-logy, Ninth Edition, Saiincieie, Voi. 3. Chapters 104i and 195
`
`Eli-iii?"
`
`Cecil Textbook of Medicine, Wyngaatden & Smith 18th edition; Chapter on “Giucocorticosteroid Therapy“,
`Wyngaarden 8: Smith 18th edition, (1988} 33.1284 31
`
`Cougar Biotechnoiogy inc. with the US. Securities and Exchange Commission, Form iii—C1388
`
`SEWE-
`
`=t at, "Pitearrneaoohiiietios and Phaimawclynamice of Systeinioally Administered Gluooooitiooids",
`CZOCK,
`Pharmacokinet {2005}, 44(1), 961—93
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`ERGUN—LONGMlRE, Berrin, et ei, " we Novel Mutations Found in a Patient with Wat—Hydroxylase Enzyme
`Befioienoy", The Journei oi Ciinioa! Endocrinology & Metabolism {2008), QiiiO}, 941794-182
`
`8
`
`D
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`FAKEH, at at, Urology {2002} 60, {1553—561
`
`steioid hormone profilee-A ieview of five cases". Aitei'netive Medicine Review (2006}, 11(1)-
`
`FRlEL, Patrick hi, et 3L, "Suppression of adrenal function by low-dose precinisone: assessment with 24-hour urinary
`
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`SNFGRMATSQN BESCLGSERE
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`Aian H. Aaerbach
`First Named inventor
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`Applicatian Number
`
`130343d0
`
`Fiiing Gate
`
`20‘: 1—02—24
`
`CGRSGGE USCNTt
`
`STA?EMENT BY APPQCANT
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`(_ Not for submission under 3? CFR 1.99)
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`Art Unit
`
`Examiner Name
`
`San Ming R. Hui
`
`Attorney Becket Number
`
`:11
`
`Etntemetarticie: httpzflciinicaitriaEs.gow’arehEveENCTG04-85353i2007_{3§_1t
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`fl
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`E
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`12
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`trifcarmation cancerning Zytiga (abiratercne acetate} from httpzir‘wvmitempenditimchipiuji‘pnrfl183238!de?
`Piatform=Desktop as of March 25‘ 2014
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`U
`
`13
`
`Einternetarticte: httpflfciinicaiti'iais.gevfciiéiahcwi‘atudyt‘NC'i't)0485303?sec=)§501
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`flit-"i
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`D M
`
`GSTAGHEL, EA. “Abiratercne in the treatment of metastatic castration-resistant prostate cancer“, Cancer
`Management Res. (2014315, nae—51
`
`1:;
`
`OSABA. 0., at at. "Heaiéh-Reiated Quality of Life in Men with Metastatic Prostate Cancer Treated with Prednisone
`atone er tvfiiwxantrone and Precinisane". J. Ciin. Oncoi. {1999), 1?(6), {2.165446%
`
`:
`
`D
`
`-----------------------+ -
`
`PETRYLAK, DR. “New Paradigms for Advanced Prostate Cancer“, Rev. Uroi. {290?}, 9, Suppl. 2, 83-312
`
`i3
`
`Prostate Cancer Principles and Practice, Taylor 8: Francis {2008) Chapter 93
`
`E
`
`1?
`
`18
`
`‘
`
`REit), It. etaL, "Annals of Oncology", Educationai and Abstract Book of the ESMO Centerence Luganc- (ti-LCLU}.
`{250?}, 18(Stippiementg}, ix173-ix174. Abstract EOPD
`
`D
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`:
`
`REMENGTON, "The Science and Practice of Pharmacy. 20th Edition {2006). p.1383-13m
`
`————————————t——————-t————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————5-—————-
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`U
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`RUN-GE, Marsctiaii 8., at at, ”Principles; of Meiecuiar Medicine; Seccnd editien; (2096} Humana Press inc. ZSBN:
`1—58829—202—9. pgs.365—3?6 and 4824184
`
`E
`
`SiLLS, irene N, et aL, "ETIa—hydroxyiase deficiency in a genetic maie and female sibiing pair‘fl int. J. Gynaecol. Gbstat.,§
`{1961}. 19, para—4179
`
`i3
`
`:21
`
`
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`Application Number
`
`130343d0
`
`Fiifing Gate
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`20‘: 1—02—24
`
`iNFGRMATiQN BESCLGSERE
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`Aiafii H. Acerbach
`First Named inventor
`
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`STfitEMENT BY APPLiCANT
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`Alt Unit
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`CGRSGoi USCNTi
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`Examiner Name
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`San Ming R. Hui
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`Attorney Docket Number
`
`22
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`Summary of Product Characteristics for Zytiga 250mg tablets (163an2014)
`
`fl
`
`_______________________+—.—_.—.—_.—.1..—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—.—_.—__________.____________
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`23
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`TANNOCK., at at, "Docetaxefi Pins Prednieone or l‘ufiitoxantrone Pius Predniaone for Advanced Prostate Cancer",
`Journal of Urology (2005). 11’3(
`). p.458
`
`{:E
`
`:
`
`The repiy cfapolicantiie. tne Proprfietor of herefi.n opposed patent} dated June 11,2013in relation to the corresponding;
`1.1820141{1144016At U3proceedings. CE
`
`i231
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`25
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`‘
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`WANG. {3. et a1.. "Hypertension due to 1721---i-1y{lroxylaee (‘911"entry", Australian and New Zealand Journal of Medicine; 13
`(1. 978.}. arr-3‘, p 295 299
`.
`
`YANG, A et a1. "(-245.roocoriicoide Suppress Turner Angiogeneie and in vivc- Growth of Prostate Cancer Cells", Clin.
`Cancer Res. , {2006) 12, 3093- 3099
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